Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery Can Prevent Post-thyroidectomy Hypoparathyroidism

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Study Overview

• Status: Recruiting
• Conditions: Surgery--Complications; Hypocalcemia; Hypoparathyroidism Postprocedural
• Intervention / Treatment: Device: NIR optical imaging camera

Detailed Description

Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to:

1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.

Measurements:

PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.

Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.

An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Lykke, MD; Phone Number: +45 35454799; Email: eva.lykke@regionh.dk
• Study Contact Backup: Name: Anders Christensen, MD, PhD; Phone Number: +45 35459786; Email: anders.christensen.03@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Eva Lykke, MD; Phone Number: +45 35454799; Email: eva.lykke@regionh.dk
    • Contact: Christian on Buchwald, MDSc, PhD; Phone Number: +45 35452370; Email: christian.von.buchwald@regionh.dk
  • Køge, Denmark, 4600
    • Recruiting
    • Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
    • Contact: Preben Homøe, DMSc, PhD; Phone Number: +45 56 63 15 00; Email: prho@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand patient information and to give written informed consent
• Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.

Exclusion Criteria:

• Not able to understand patient information and to give written informed consent
• Previous parathyroid surgery or other parathyroid decease
• Age under 18

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Plus NIR optical imaging; NIR optical imaging assisted identification of parathyroid glands during thyroid surgery	Device: NIR optical imaging camera; NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
No Intervention: Minus NIR optical imaging; Conventional identification of parathyroid glands during thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hypoparathyroidism	Hypoparathyroidism defined as: PTH < 1,6 pmol/L and based on European Society of Endocrinology Clinical Guideline	24 months-follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hypocalcemia	Hypocalcemia defined as: ionized Calcium < 1,15 mmol/L	12 months follow-up
Time	Duration of surgery	Immediately after surgery
Parathyroidglands identified by NIR light	Number of identified by NIR light vs. white light	During surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Cluster for molecular imaging, Denmark; Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
• Investigators: Study Director: Christian von Buchwald, MDSc, PhD, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhe C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16.
• Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31.
• Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6.

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2019
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 6, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: near-infrared; total thyroidectomy; parathyroidectomy; optical imaging; NIR; thyroide surgery; compltion thyroidectomy; autofluorescense
• Additional Relevant MeSH Terms: Metabolic Diseases; Endocrine System Diseases; Parathyroid Diseases; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hypoparathyroidism; Hypocalcemia
• Other Study ID Numbers: H19010211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No